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Adverse Drug Events Nearly Tripled Since 1998

Twenty percent of drugs account for 87 percent of adverse events in the United States

MONDAY, Sept. 10 (HealthDay News) -- The number of adverse events reported to the U.S. Food and Drug Administration has nearly tripled since 1998, with 20 percent of drugs accounting for 87 percent of those events, researchers report in the Sept. 10 issue of the Archives of Internal Medicine.

Thomas J. Moore, from the Institute for Safe Medicine Practices in Huntingdon Valley, Penn., and colleagues analyzed adverse drug events and medication errors reported to the FDA through the Adverse Event Reporting System from 1998-2005.

The researchers found that the number of serious adverse events increased 2.6-fold and the number of fatal adverse drug events increased 2.7-fold. Drugs involved in safety withdrawals initially accounted for 26 percent of events but fell to less than 1 percent by 2005. The number of serious events from 13 new biotechnology products increased 15.8-fold.

"These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period," Moore and colleagues conclude. "The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."

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